Sign in
HT

HERON THERAPEUTICS, INC. /DE/ (HRTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 net revenue was $38.213M (+16.5% YoY), with positive Adjusted EBITDA of $1.542M; diluted EPS was -$0.10 as net loss increased due to an $11.339M loss on debt extinguishment .
  • Acute Care net revenue rose to $12.347M (+67.2% YoY) led by ZYNRELEF ($9.313M, +49% YoY) and APONVIE ($3.034M, +173% YoY); Oncology held steady at $25.866M with CINVANTI up ~6% YoY and SUSTOL down ~31% YoY .
  • Against S&P Global consensus, revenue modestly missed ($38.21M actual vs $39.03M estimate) and EPS missed (-$0.10 actual vs -$0.013 estimate); management reaffirmed FY 2025 net revenue guidance of $153–$163M and Adjusted EBITDA of $9–$13M, while the call contained an inconsistent EBITDA range reference [*S&P Global estimates disclaimer].
  • Key catalysts: permanent product-specific J-code for ZYNRELEF effective Oct 1, 2025, early October demand step-up, and momentum from the VAN device and dedicated APONVIE sales team; cash and short-term investments stood at $55.5M at quarter-end .

What Went Well and What Went Wrong

What Went Well

  • Acute Care acceleration: ZYNRELEF net revenue grew 49% YoY and APONVIE grew 173% YoY; early October unit demand for ZYNRELEF stepped up ~17–18% MoM, signaling potential trend inflection .
  • Commercial execution: CEO highlighted new initiatives (CrossLink Ignite, VAN, dedicated APONVIE team) “positively impacting our commercial execution and driving increased demand” .
  • Reimbursement clarity: ZYNRELEF’s permanent product-specific J-code went live Oct 1, expected to streamline billing across CMS and commercial payers; NOPAIN Act adoption building, with management citing ~75% coverage of indicated procedures .

What Went Wrong

  • Gross margin compression: product gross margin fell to 68.8% (from 71.2% in Q3’24) due to ~$1.4M in reserves/write-offs and higher unit costs; adjusted GM would be ~74.5% excluding one-time stocking charges per CFO .
  • Bottom line impact: net loss widened to -$17.5M primarily from the $11.3M loss on debt extinguishment taken in the quarter .
  • SUSTOL erosion: net revenue declined ~31% YoY and management plans a wind-down over the next 12 months ahead of a potential late-2027 reintroduction contingent on development/regulatory progress .

Financial Results

Core P&L metrics vs prior year and prior quarter

MetricQ3 2024Q2 2025Q3 2025
Net Revenue ($USD Millions)$32.81 $37.20 $38.21
Gross Profit ($USD Millions)$23.35 $27.34 $26.30
Gross Profit Margin %71.2% 73.5% (calc from $27.34/$37.20) 68.8%
Total Operating Expenses ($USD Millions)$27.81 $28.98 $30.39
Adjusted EBITDA ($USD Millions)$(0.355) $1.771 $1.542
Net Loss ($USD Millions)$(4.85) $(2.38) $(17.50)
Diluted EPS ($)$(0.03) $(0.02) $(0.10)

Segment breakdown (Net Revenue)

Metric ($USD Thousands)Q3 2024Q2 2025Q3 2025
Acute Care$7,385 $10,653 $12,347
• APONVIE$1,140 $2,464 $3,034
• ZYNRELEF$6,245 $8,189 $9,313
Oncology$25,425 $26,547 $25,866
• CINVANTI$22,662 $24,143 $23,955
• SUSTOL$2,763 $2,404 $1,911
Total Net Revenue$32,810 $37,200 $38,213

KPIs (adoption/penetration)

KPIQ3 2024Q3 2025
ZYNRELEF average daily units882 1,127
ZYNRELEF ordering accounts705 833
APONVIE average daily units418 998
APONVIE ordering accounts299 405

Quarterly trajectory (additional context)

MetricQ1 2025Q2 2025Q3 2025
Net Revenue ($USD Millions)$38.90 $37.20 $38.21
Diluted EPS ($)$0.01 $(0.02) $(0.10)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net RevenueFY 2025$153–$163M (Original, Q1, Q2) $153–$163M (Q3 reiterated) Maintained
Adjusted EBITDAFY 2025$0–$8M (Original) → $4–$12M (Q1) → $9–$13M (Q2) $9–$13M (Q3 reiterated) Raised in Q2; Maintained in Q3

Notes:

  • CFO on the call stated “Adjusted EBITDA of $9M–$30M,” which appears inconsistent with the press release guidance of $9M–$13M; we anchor to the formal press release figures .

Earnings Call Themes & Trends

TopicQ1 2025Q2 2025Q3 2025Trend
Acute Care product momentumAcute Care +89.4% YoY; ZYNRELEF +60.4% Acute Care +55.5% YoY; VAN transition; dedicated APONVIE team planned Acute Care +67.2% YoY; ZYNRELEF +49% YoY; APONVIE +173% YoY; October demand step-up Strengthening sequential momentum
Reimbursement/policy tailwindsNOPAIN Act effective Apr 1 CMS permanent product-specific J-code effective Oct 1 announced J-code live Oct 1; ~75% coverage across indicated procedures; CMS TEAMS model tailwinds Improving coverage/access
Oncology outlookCINVANTI stable; SUSTOL down YoY CINVANTI -3.1% YoY; SUSTOL -43.4% YoY CINVANTI +5.7% YoY; SUSTOL -30.8% YoY; SUSTOL wind-down over 12 months Stable CINVANTI; SUSTOL declining
Commercial executionVAN launch; CrossLink partnership Sales force reorg; distributor incentives “Friction removal and focus”: VAN, Ignite program, dedicated APONVIE team; weekly units at highs Execution sharpening
R&D/dev roadmapPFS targeted early 2027 PFS on track PFS registration batches/stability initiated; anticipated 2027 approval if successful Progressing per plan
Capital structure/liquidityCash/ST investments $50.7M Capital restructuring executed Cash/ST investments $55.5M; $13.1M added via transactions Improved flexibility

Management Commentary

  • CEO: “We’re encouraged by the early signs that [new initiatives] are positively impacting our commercial execution and driving increased demand for our products.”
  • COO: “The theme is friction removal and focus… VAN made prep easier… Ignite kept distributors focused on winnable accounts… permanent J-code clarity streamlining reimbursement.”
  • CFO: “Product gross profit… was 68.8%… decreased from 71.2%… due to $1.4M in reserves/write-offs and ~$1.3M higher unit costs (supplier mix)… reaffirming net revenue of $153–$163M and Adjusted EBITDA of $9–$13M.”
  • Development: “Pre-filled syringe… registration batches manufactured, stability initiated… if successful, approval anticipated in 2027.”

Q&A Highlights

  • ZYNRELEF demand: Early October up ~17–18% MoM; management cautioned not to extrapolate a single month .
  • Gross margin normalization: Excluding ~$2.2M stocking charge, GM ~74.5%, in line with recent quarters; CFO affirmed .
  • Interest expense trajectory: Post-refinancing, net interest expense run-rate discussed around ~$2.5M going forward .
  • APONVIE ramp/inventory: Minimal inventory stocking benefit from 200mg VAN; dedicated APONVIE team fully trained in October to support Q4 momentum .
  • Policy tailwinds: NOPAIN Act adoption spreading to commercial payers (e.g., Aetna, Cigna), ~75% coverage of indicated procedures, CMS TEAMS model and outpatient shifts to support use cases .
  • SUSTOL plan: Wind-down over next 12 months with potential reintroduction around late 2027 pending updates; manage transition responsibly .

Estimates Context

MetricQ3 2025 ActualQ3 2025 ConsensusSurpriseQ4 2025 Consensus
Revenue ($USD)$38,213,000 $39,031,250*Miss (~$0.82M)$39,825,000*
Primary EPS ($)-0.10 -0.01333*Miss-0.03*
EBITDA ($USD)$(3,478,000)* (GAAP EBITDA proxy)N/AN/AN/A

Values marked with an asterisk are retrieved from S&P Global.

Implications: Consensus likely to edge up Acute Care trajectories but adjust for margin headwinds and the debt extinguishment impact; near-term EPS expectations may remain conservative given SG&A investments and product mix .

Key Takeaways for Investors

  • Acute Care is now a clear growth engine: ZYNRELEF and APONVIE showed strong YoY gains with operational KPIs inflecting; weekly units in late Sep–Oct hit highs, supported by VAN, J-code, and focused sales execution .
  • Reimbursement clarity is a catalyst: The permanent ZYNRELEF J-code and growing NOPAIN Act adoption (including commercial payers) should reduce friction in billing and expand access into outpatient settings .
  • Oncology remains a cash-generating anchor: CINVANTI continues to hold, mitigating Acute Care ramp volatility; watch competitive pricing pressure and potential cross-pull from APONVIE hospital relationships .
  • Margin watch: Near-term gross margin impacted by reserves/write-offs and supplier mix; excluding one-time items, underlying GM appears consistent with prior quarters—monitor cost mix and inventory discipline .
  • Balance sheet flexibility improved: Cash/ST investments of $55.5M; capital transactions added $13.1M; debt extinguishment cleans up the structure despite the one-time P&L hit .
  • FY25 guide intact: Net revenue $153–$163M and Adjusted EBITDA $9–$13M reiterated; anchor to press release figures amidst call-range inconsistency; Q4 execution and policy tailwinds are key to hitting the upper half .
  • Trading setup: Near-term narrative hinges on Acute Care demand trend sustainability and reimbursement tailwinds; any further evidence of October step-up persistence and acceleration of APONVIE adoption could be stock-positive, while margin surprises or policy setbacks could pressure the shares .